The BARBER Trial: Music and Binaural Beats During Prostate Biopsy

NCT07692893 | Completed

• 1 other identifier: BARBER-136-2023
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to learn whether listening to classical music or binaural beats could reduce anxiety and pain in adult men undergoing prostate biopsy. The main questions it aimed to answer were:

• Does listening to classical music reduce anxiety and pain during prostate biopsy compared with no music?
• Does listening to classical music with binaural beats reduce anxiety and pain during prostate biopsy compared with classical music alone or no music? Researchers compared three groups of participants: one group listened to classical music, one group listened to the same music with binaural beats, and one group did not listen to music. Participants were asked to complete anxiety questionnaires before and after the biopsy. They also rated their pain after the procedure, and blood pressure and heart rate were recorded before and after the biopsy.

Conditions

Anxiety; Prostate Biopsy; Pain

Keywords

Prostate biopsy; Anxiety; Pain; Binaural beats; Classical music; Music intervention; Randomized trial

Outcome Measures

Primary Outcomes (1)

• Change in State Anxiety Score

  Change in state anxiety score from baseline to after prostate biopsy, assessed using the State-Trait Anxiety Inventory Form Y-1. The change was compared between the study groups.

  Baseline and 15 minutes after prostate biopsy

Secondary Outcomes (1)

• Pain Score After Prostate Biopsy

  15 minutes after prostate biopsy

Study Arms (3)

Binaural Beats Group

EXPERIMENTAL

Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure.

Behavioral: Binaural beats auditory intervention

Classical Music Group

ACTIVE COMPARATOR

Participants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure.

Behavioral: Classical music auditory intervention

No Music Group

ACTIVE COMPARATOR

Participants underwent the prostate biopsy procedure without listening to music or binaural beats.

Behavioral: No Music Group

Interventions

Binaural beats auditory intervention BEHAVIORAL

Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure. The binaural beat was generated by presenting a 384-Hz tone to the right ear and a 378-Hz tone to the left ear. The audio track was delivered through wireless stereo headphones.

Binaural Beats Group

Classical music auditory intervention BEHAVIORAL

Participants listened to Samuel Barber's \*Adagio for Strings\* during the prostate biopsy procedure. The same musical track used in the binaural beats group was delivered without embedded binaural beats through wireless stereo headphones.

Classical Music Group

No Music Group BEHAVIORAL

Participants underwent the prostate biopsy procedure without listening to music or binaural beats.

No Music Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 18 years or older
• Scheduled to undergo prostate biopsy
• Italian speaking
• At least formal schooling, defined as 1 to 8 years of education
• Able to understand the study procedures and provide written informed consent

You may not qualify if:

• Severe hearing loss requiring the use of a hearing aid
• History of epilepsy
• Psychiatric disorders
• History of chronic pelvic pain syndrome
• Chronic use of antidepressant and/or analgesic drugs
• Use of analgesic drugs within 24 hours before the procedure
• Previous prostate biopsy

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, TS, 34100, Italy

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FEBU

Model Details: Participants were randomized in a 1:1:1 ratio to one of three parallel groups: classical music, classical music embedded with binaural beats, or no music. Each participant received only the assigned intervention during the prostate biopsy procedure.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)